China NMPA Drug Inspection - Overseas Pharmaceutical (Huadian) Co., Ltd. - Belladonna slices

This document, issued by the Office of Tianjin Municipal Market and Quality Supervision and Management Commission on July 2, 2018, announces the findings of drug supervision and sampling inspections. The inspections identified several substandard drug products from different manufacturers, leading to investigations and enforcement actions by municipal market supervision and law enforcement departments. Three specific instances of non-compliance were highlighted. Tianjin Zhongtian Pharmaceutical Co., Ltd.'s Pudilan Anti-inflammatory Tablets (Batch ZT110255) were found to have a "Weight Difference," failing to meet the National Medical Products Administration Standard WS 3-B-0649-2002. Similarly, Boric Acid Glycerin Ear Drops (Batch 20180402), prepared by Tianjin Municipal Public Security Hospital, were deemed substandard due to an unacceptable "pH Value" according to the 《Tianjin Municipal Medical Institution Preparation Standards》 2016 Edition. Finally, Overseas Pharmaceutical (Huadian) Co., Ltd.'s Belladonna Tablets (Batch 20170901) exhibited issues with both "Appearance" and "Weight Variation," violating the 《Chinese Pharmacopoeia》 2015 Edition, Part I. The regulatory framework for these inspections involves national standards like those from the National Medical Products Administration and the Chinese Pharmacopoeia, alongside local standards for medical institution preparations. The announcement specifies that the identified substandard drugs are being "investigated and dealt with... in accordance with the law," indicating mandatory corrective actions and potential penalties for the implicated manufacturers.